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Trial record 11 of 221 for:    heart disease AND stroke AND California

Statins and Endothelial Function in Patients With Coarctation of the Aorta

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ClinicalTrials.gov Identifier: NCT00767572
Recruitment Status : Terminated (low enrollment)
First Posted : October 7, 2008
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of California, San Francisco

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Coarctation of the Aorta
Interventions: Drug: atorvastatin
Drug: Sugar pill

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from the UCSF Adult Congenital Heart Disease Clinic between July 2008 and July 2009. All reviewed the study protocol and agreed to participate. There was no compensation for study participants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded if they did not have prior repair of aortic coarctation or could not participate in all 4 study visits.

Reporting Groups
  Description
Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin Patients were randomized to atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment was performed before and after each 12 week intervention.

Participant Flow for 3 periods

Period 1:   First Intervention (12 Weeks)
    Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 

Period 2:   Washout (4 Weeks)
    Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 

Period 3:   Second Intervention (12 Weeks)
    Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin Patients were randomly assigned to receive atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment were performed before and after each 12 week intervention.

Baseline Measures
   Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   12 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 35  (8.8) 
Gender 
[Units: Participants]
 
Female   4 
Male   8 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures

1.  Primary:   Pre-post Change in Brachial Artery Reactivity   [ Time Frame: Baseline, 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
All patients were enrolled and completed the study interventions and assessments. Technical problems with measurements may have led to some unreliable data.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Doreen DeFaria Yeh
Organization: UCSF
phone: 617-643-7024
e-mail: ddefariayeh@partners.org



Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00767572     History of Changes
Other Study ID Numbers: H7151-32792-01
First Submitted: September 24, 2008
First Posted: October 7, 2008
Results First Submitted: November 9, 2012
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2013